Table 5.
Summary of CVOT data for GLP-1 RAs currently marketed in the United States
| Agent | Trial Name (clinicaltrials.gov Identifier) | Summary of Key Findings |
|---|---|---|
| Liraglutide77 | LEADER Study (NCT01179048) | The primary composite CV outcome occurred in significantly fewer patients in the liraglutide group (13.0%) than the placebo group (14.9%; HR, 0.87; 95% CI, 0.78 to 0.97; P=0.01 for superiority) |
| Fewer patients died from CV causes in the liraglutide group (4.7%) than the placebo group (6.0%; HR, 0.78; 95% CI, 0.66 to 0.93; P<0.01) | ||
| Death from any cause was lower in the liraglutide group (8.2%) than the placebo group (9.6%; HR, 0.85; 95% CI, 0.74 to 0.97; P=0.02) | ||
| Lixisenatide78 | ELIXA Trial (NCT01147250) | Lixisenatide was noninferior to placebo for the primary composite CV outcome (HR, 1.02; 95% CI, 0.89 to 1.17; P<0.001) |
| No significant between-group differences in the rate of hospitalization for heart failure (HR, 0.96; 95% CI, 0.75 to 1.23) | ||
| Exenatide79 | EXSCEL (NCT01144338) | Trial in progress; estimated completion in April of 2018 |
| Dulaglutide80 | REWIND (NCT01394952) | Trial in progress; estimated completion in July of 2018 |
| Albiglutide81 | HARMONY Outcomes (NCT02465515) | Trial in progress; estimated completion in May of 2019 |
EXSCEL, Exenatide Study of Cardiovascular Event Lowering Trial; REWIND, Researching Cardiovascular Events with a Weekly Incretin in Diabetes; HARMONY Outcomes, A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus.